Tegretol (carbamazepine) and Depakote (valproic acid) can be life-saving drugs for people who suffer from epileptic seizures. But these serious medications come with a host of potential side effects that might be unacceptable for pregnant women.
Astonishingly, according to a study by Johns Hopkins published in the journal Epilepsy & Behavior, 1 in 5 U.S. neurologists might be unaware that Tegretol and Depakote can cause severe birth defects and malformations if they are consumed by mothers-to-be.
This is not the first time concerns have been voiced that caregivers fail to acknowledge epilepsy drug risks; we blogged earlier this year on the same topic.
As reported on AboutLawsuits.com, the neurologists who participated in the survey also were unaware that some epilepsy drugs can increase the risk of suicide, and that Asian patients should undergo special screening before being placed on Tegretol.
“There is poor communication from the FDA to specialists, and there’s some risk to patients because of this,” said Dr. Gregory L. Krauss in a Johns Hopkins news release. Krauss is a professor of neurology who led the research team. “Unless it’s a major change requiring the FDA to issue a black box warning on a product, important information appears to be slipping through the cracks. We need a more systematic and comprehensive method so that doctors receive updated safety warnings in a format that guarantees they will see and digest what they need to protect patients.”
Depakote came on the market in 1978 and is a widely used epilepsy drug. But in 2006, the FDA added a “black box” warning to the medication. Such a designation denotes the risk of serious or life-threatening side effects of otherwise approved drugs.
The concern over Depakote is the risk to a fetus–1 in 5 pregnant women who took it gave birth to a child with malformations or a birth defect.
According to AboutLawsuits, many families have sued Abbott Laboratories on behalf of their children, alleging that the drug maker failed to adequately warn consumers or the medical community about the potential risks.
Studies also have associated Tegretol with a risk of birth defects, especially spina bifida, a developmental malformation of the spinal cord.
A 3-year-old study publish in the British medical journal BMJ concluded that using carbamazepine during pregnancy raised the risk of delivering a child with spina bifida by 2.6 times. More than 3 in 100 women who took the drug gave birth to a child with spina bifida.
Taking epilepsy drugs during pregnancy also has been associated with children’s developmental delays, including motor control and speech problems and autism.
Always ask your doctor about potential side effects of medication, but especially if you are pregnant or planning to become pregnant. And because some providers are unacceptably unaware of drug risks, conduct your own research on Medline Plus, a database provided by the National Institutes of Health.